Hepatitis C has rapidly become a major public health problem, and accessibility to new and affordable treatments has been highly sought after. Hepatitis C virus (HCV) can be transmitted by blood transfusions or contaminated needles; although no symptoms are present at the outset, chronic Hepatitis C infection can give rise to liver complications such as cirrhosis or liver cancer. As the leading infectious killer in the U.S., HCV chronically infects 2.7 million to 3.5 million people in the U.S. Since first coming onto the U.S. market in in 2013, Sovaldi has been one of the few, if only, medications to successfully treat Hepatitis C at a cure rate of over 90% after 12 weeks of treatment, with few side effects. Sovaldi holds considerable exclusivity due to its novelty. As such, Sovaldi costs $1,000 per pill, leading to a costly $84,000 for a 12-week treatment regimen. In contrast, Sovaldi costs less than $1 per pill.
Sovaldi pricing has received nationwide attention; to the point of rare bi-partisan partnership taking action. On July 11, 2014, Senate Finance Committee Ranking Member Ron Wyden (D-Oregon) and senior Committee Member Chuck Grassley (R-Iowa) requested information on Gilead Sciences’ pricing tactics that have negatively affected public payers’ access to Sovaldi. The lawmakers deemed the investigation pertinent since the medication raises “serious questions about the extent to which the market for this drug is operating efficiently and rationally,” and Sovaldi’s price “appears to be higher than expected given the costs of development and production and the steep discounts offered in other countries.” After an 18-month investigation and hearing, Congress released an extensive report on December 1, 2015, detailing Gilead Sciences’ pricing, marketing, and development mechanisms on Sovaldi and Harvoni.
Among other conclusions explaining the price variation, the report determined that Gilead did not easily provide access to states’ Medicaid programs. Medicaid programs spent $1.3 billion on Sovaldi, before rebates, in 2014 alone, yet less than 2.4 percent of Medicaid-eligible patients with HCV received treatment. In fact, many states have resorted to restricting access to covering a limited number of Medicaid patients. Some states, such as New Mexico, limit Medicaid coverage to the sickest patients, or those who have pre-existing liver damage. These states require healthcare providers to “perform risky liver biopsies on patients to prove how sick they are, or wait until patients have late-stage liver disease before they can be eligible for coverage.”
A recent study examined how consistently state Medicaid programs abided by recommendations made by the American Association for the Study of Liver Disease and the Infectious Diseases Society of America on treating, managing, and preventing HCV. Out of the 42 states (including the District of Columbia) that had publicly available Medicaid reimbursement criteria, 74% restricted access to Solvaldi to those with advanced fibrosis or cirrhosis, which occurs at stage F4 of the disease. Furthermore, a majority of states limit Medicaid reimbursements to patients who have abstained from drug and alcohol use for a certain period of time, even those who have undergone opioid substitution therapy. From these findings, the study concluded that current state Medicaid reimbursements may violate federal Medicaid law, which provides that state Medicaid programs plans must include drugs manufactured by pharmaceutical companies that have negotiated rebate plans with the Secretary of Health and Human Services, except for those under the restrictive lists of drugs.
Some states have rearranged their Medicaid program policies by forming a pool with other states and purchasing alternative treatments exclusively in an effort to force coverage away from Solvaldi. As of January 2015, Missouri and 24 other states successfully reached a negotiation with AbbVie to secure an extra 20 to 30 percent rebate system for their Medicaid patients. However, these negotiations place restrictions on Medicaid enrollees, who are required to stay sober for 90 days before beginning the Viekira Pak treatment. Although Missouri anticipates to save $4.2 billion from these rebates, the lag time of over six months for calculating rebates into the state budget means it will be too soon to determine the overall cost savings on Medicaid spending. The Missouri state department also plans to provide Solvaldi to an estimated 15 to 20% of HCV patients who cannot be effectively treated by Viekira Pak, which implies that the medication cannot clinically treat all people infected by HCV. Exclusive Medicaid negotiations with alternative treatments could lead to unintended leftover costs from providing for patients whom Viekira Pak is not a valuable option.
Recent litigation on the state level has addressed issues of Medicaid coverage of Sovaldi. In B.E. v. Teeter, Washington Medicaid enrollees, who were HCV patients that did not receive DAA medication, brought a class action suit against the Washington State Health Care Authority (“WHCA”), under claims of violating the Medicaid Act for categorically excluding them from “medically necessary” drugs. The federal district court sided with the plaintiffs’ argument, granting their motion for preliminary injunction, given that the plaintiffs had satisfied all the factors necessary to warrant such a remedy. In doing so, the court determined that the plaintiffs’ evidence “will likely establish that the WHCA is failing to follow its own definition of medical necessity by refusing to provide DAAs to monoinfected enrollees with a F0-F2 score and offering only “monitoring” in lieu of this breakthrough treatment.”
This decision significantly marked the first time that a federal court deemed restrictions to Hepatitis C state Medicaid programs as illegal, and thus could provide a precedent for other states to follow suit. Consumers from California and, again Washington, have also recently filed suits against private insurance companies, such as Anthem Blue Cross and Group Health Cooperative. Since these lawsuits have involved gathering a class of injured plaintiffs, however, issues of class certification under Rule 23(a) and 23(b)(2) will need to be resolved, as they were in B.E. v. Teeter. As such, law suits filed on behalf of a consumer class may not be the most efficient resolution, since time constraints and litigation costs could prolong the desired remedy, if the court chooses to grant it.
Massachusetts employs a fee-for-service program for distributing Solvaldi. As such, the state has relatively unrestricted access to Sovaldi compared to other states; yet, only an estimated 1,075 members have been approved for treatment regimens among the 7,658 members living with HCV. In an unprecedented move, on January 2016, Massachusetts Attorney General Maura Healey issued a letter warning to sue Gilead Sciences for potentially violating unfair trade practice under section 2 of chapter 93A of the Mass. Gen. Laws. However, the lawsuit may not contain the merits required to bring an action under consumer protection law. The AG eventually spent months negotiating with Gilead Sciences and recently, on June 30, 2016, reached a new drug rebate program to provide unrestricted coverage to MassHealth patients in need of Hepatitis C treatment. Since the MassHealth rebate program was recently implemented on last August 1st, the effectiveness of the pricing solution will need to be monitored further to determine whether Medicaid coverage of Solvaldi is expanded to offer more treatments to those in need.